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The Efficacy in Treatment of Facial Melasma Combined With Thulium 1927-nm Fractional Laser and Topical H2R Antagonist

NCT06313307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-15

No results posted yet for this study

Summary

Melasma is a hyperpigmentary disorder of the skin especially of the face. Compared with normal skin, histologic features of melasma include the enhanced activity of melanocytes, higher solar elastosis in upper dermis, basement membrane disruption which promotes melanocytes and melanin into the dermis, increased vascularization, and an increased number of mast cells.

1927nm fractional laser was approved to treat melasma with no major side effects, however,hyperpigmentation and recurrence occasionally happened after laser therapy. Mast cells may paly a key role in the refractory melasma and hyperpigmentation. We hypothesized that laser treatment may stimulate the activation of pre-existing mast cell in melasma skin and promote mast cell proliferation and degranulation to release mediators such as histamine (HA). HA has been demonstrated to increase the melanin content and tyrosinase activity of melanocytes and induce melanogenesis and morphological changes by activating cAMP-PKA pathway through H2 receptors on melanocytes5. H2R antagonist(H2RA) can suppress pigmentation by reducing the increase of activated melanocytes by UVB irradiation.

In the present study, the investigators speculated that H2RA can enhance the efficacy of laser treatment of melasma and block the histamine-mediated melanogenesis and dendricity to prevent postoperative hyperpigmentation. The investigators combined 1927nm fractional laser with topical famotidine for melasma as a new therapeutic strategy to treat melasma.The investigators performed a split-face, single-blinded study to evaluate the efficacy and safety of 1927nm fractional laser with topical famotidine for the treatment of facial melasma.

Conditions

  • Melasma

Interventions

COMBINATION_PRODUCT

topical H2R antagonist

Topical H2RA (2% famotidine solution solved in double-distilled water (containing poloxamer 407, glycerol, lauryl alcohol polyether-4, polyethylene glycol-8, and propylene glycol)) was applied topically twice per day in the morning and the evening for 16 weeks.

DEVICE

Thulium 1927-nm Fractional Laser

1927nm fractional laser (South Korea, WONTECH, Lavieen) was performed with 4-week interval (Week 0, 4, 8, 12 and 16) for a total of 4 treatments. The parameter of 1927nm fractional laser was as follows: duration 600-800um, 10w, density 0.8mm, 1 pass.

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • ZHAO WANG · The second affiliated hospital of Xian Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-11-25
Completion
2023-11-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06313307 on ClinicalTrials.gov